Criteria for Transcatheter Aortic Valve Replacement (TAVR)

Any patient diagnosed with severe aortic stenosis that is deemed inoperable or high risk for open aortic valve replacement can be referred for TAVR evaluation. All potential candidates seen for evaluation will be educated and assessed by the multidisciplinary Robert Wood Johnson University Hospital team that includes cardiac surgeons, vascular surgeons, interventional cardiologists, cardiac anesthesiologists, echocardiologists, and a clinical nurse coordinator. Although some contraindications to TAVR are absolute, many are relative and are determined by individual program policy and experience. Patients should be presumed to be acceptable candidates until proven otherwise. If there is any question regarding an individual’s candidacy, the patient should be referred and the TAVR team will make the final determination.

Inclusion Criteria

  • Patient has severe aortic valve stenosis per echo: mean gradient >40 mmHg or jet velocity greater than 4.0m/s and an aortic valve area of <0.8 cm2 or indexed EOA <0.5 cm2/m2
  • NYHA >2
  • Probability of death or serious, irreversible morbidity >50%

Exclusion criteria

  • MI < 1 month before treatment
  • Congenital unicuspid or bicuspid aortic valve or non-calcified aortic valve
  • Mixed aortic valve disease
  • Cardiac procedure resulting in a permanent implant performed within 30 days of the procedure or within 6 months if drug eluting coronary stent implanted
  • Severe mitral insufficiency
  • Leukopenia, acute anemia, thrombocytopenia, bleeding diathesis or coagulopathy
  • Untreated clinically significant coronary artery disease
  • Hemodynamic or respiratory instability within 30 days of screening
  • Need for emergency surgery
  • Hypertrophic cardiomyopathy
  • Severe ventricular dysfunction
  • ECHO evidence of intracardiac mass, thrombus or vegetation
  • Active peptic ulcer or active GI bleeding within 3 months prior to procedure
  • A known contraindication to anticoagulation or inability to be anticoagulated for the procedure
  • Native aortic annulus size <18mm or >25mm
  • CVA, TIA or cluster within 6 months of the procedure
  • Renal insufficiency and/or end-stage renal disease requiring dialysis at the time of screening
  • Estimated life expectancy <12 months due to non-cardiac conditions
  • Significant aortic disease, such as abdominal aortic or thoracic aneurysm, marked tortuosity, aortic arch atheroma
  • Ileofemoral vessel characteristics that would preclude safe placement of the introducer sheath such as severe obstructive calcification, severe tortuosity or vessel’s size
  • Participating in an investigational drug or another device study
  • Active endocarditis or other active infections within 6 months of the procedure
  • Bulky calcified aortic valve leaflets in close proximity to coronary ostia